Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77 [AZT] The Supreme Court of Canada in AZT referred to the public interest in:
- avoiding cluttering the public domain with useless patents, and granting monopoly rights in exchange for misinformation or speculation; and
- early disclosure of inventions, even before their utility has been fully verified by tests.
With respect to the first point, granting useless patents and monopoly rights for misinformation has a chilling effect on other researchers and impedes others in their search for a real solution to the same problem. Moreover, it would be unfair to the public to grant monopoly rights in exchange for misinformation or speculation, since the public receives nothing useful in return. In the case of speculation, the inventor is offering nothing to the public but wishful thinking in exchange for locking up potentially valuable research turf
. Speculative patents, if permitted, would turn the patent system into a lottery that rewards those with deep pockets.
With respect to the second point, not only is the early disclosure of inventions is in the public interest, but it would be unfair to a patentee to require the patentee to demonstrate an invention’s usefulness through tests.
The concept of sound prediction
, in which utility can be predicted in advance of complete testing, balances these competing public interests. Predicted utility requires that the invention must not have been a lucky guess
or mere speculation at the time the inventor filed for the patent.
3 … For the Commissioner of Patents to have allowed Glaxo/Wellcome a patent based on speculation would have been unfair to the public. For him to have required Glaxo/Wellcome to demonstrate AZT’s efficacy through the clinical tests required by the Minister of Health for approval of a new drug for medical prescription would have been unfair to Glaxo/Wellcome. The disclosure made in the patent was and is of real use and benefit … . The fact remains that Glaxo/Wellcome, by making the disclosure, has fulfilled its side of the bargain with the public, and is by law entitled to legal protection for what it has disclosed.
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37 A patent, as has been said many times, is not intended as an accolade or civic award for ingenuity. It is a method by which inventive solutions to practical problems are coaxed into the public domain by the promise of a limited monopoly for a limited time. Disclosure is the quid pro quo for valuable proprietary rights to exclusivity which are entirely the statutory creature of the Patent Act. Monopolies are associated in the public mind with higher prices. The public should not be expected to pay an elevated price in exchange for speculation, or for the statement of any mere scientific principle or abstract theorem
(s. 27(3)), or for the discovery
of things that already exist, or are obvious. The patent monopoly should be purchased with the hard coinage of new, ingenious, useful and unobvious disclosures.
…
45 … The grant of a patent monopoly for 17 years (20 years after October 1, 1989) creates, and is intended to create, serious anti-competitive effects. Once the subject matter of the patent is fenced in by the claims, others trespass (advertently or inadvertently) on the forbidden territory at their peril. The boundary is defended by a considerable arsenal of remedies conferred by the Patent Act, including an accounting of the infringer’s profits in an appropriate case. Patent litigation is usually protracted and costly. (The present litigation commenced in 1990 and took 12 years to get here.) There is in the meantime a chilling effect on other researchers. They will tend to invest their talents in less litigious areas. Parliament considered this chilling effect to be a worthwhile price for the disclosure of a new and useful
invention, bringing into the public domain information that might otherwise remain a trade secret, but there is nothing in the Act to suggest that Parliament was prepared to accept the chilling effect in exchange for nothing but speculation.
46 Glaxo/Wellcome argues that where the subject matter of the patent is a new use for an old chemical compound, it is enough that the invention is reduced to a definite and practical shape by the formulation of a written or oral description
. This cannot be correct. The concept might be beautifully described but at the same time be quite wrong and misleading to people who consult it. In such a case, the public would be spending its monopoly rights for misinformation, and in the process litter the patent registry with useless patents that might impede others in their search for a real solution to the same problem.
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52 … Glaxo/Wellcome claimed a hitherto unrecognized utility but if it had not established such utility by tests or sound prediction at the time it applied for its patent, then it was offering nothing to the public but wishful thinking in exchange for locking up potentially valuable research turf for (then) 17 years. …
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55 In the present case, by contrast, if the utility of AZT for the treatment of HIV/AIDS was unpredictable at the time of the patent application, then the inventors had not made an invention and had offered nothing to the public in exchange for a 17-year monopoly except wishful thinking.
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66 The doctrine of sound prediction
balances the public interest in early disclosure of new and useful inventions, even before their utility has been verified by tests (which in the case of pharmaceutical products may take years) and the public interest in avoiding cluttering the public domain with useless patents, and granting monopoly rights in exchange for misinformation.
…
69 With respect, I think Parliament intended to get something more than speculation in exchange for the grant of a patent monopoly (a point which is further discussed below). On the other hand, I do not think, with respect, that the doctrine of sound prediction is limited to the narrow ambit ascribed to it by the trial judge. Once it is accepted that in appropriate circumstances utility can be predicted in advance of complete testing (whether of untested chemical compounds or otherwise), there seems no reason in principle why the doctrine should not be applied more generally, depending, of course, on the expert evidence. There is no doubt that care must be taken that the doctrine is not abused, and that sound prediction is not diluted to include a lucky guess or mere speculation. The public is entitled to obtain a solid teaching in exchange for the patent rights.
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80 In my view, with respect, Glaxo/Wellcome’s proposition is consistent neither with the Act (which does not postpone the requirement of utility to the vagaries of when such proof might actually be demanded) nor with patent policy (which does not encourage the stockpiling of useless or misleading patent disclosures). Were the law to be otherwise, major pharmaceutical corporations could (subject to cost considerations) patent whole stables of chemical compounds for all sorts of desirable but unrealized purposes in a shot-gun approach hoping that, as in a lottery, a certain percentage of compounds will serendipitously turn out to be useful for the purposes claimed. Such a patent system would reward deep pockets and the ingenuity of patent agents rather than the ingenuity of true inventors.
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84 … In the broader context of the Patent Act, as well, there is good reason to reject the proposition that bare speculation, even if it afterwards turns out to be correct, is sufficient. An applicant does not merit a patent on an almost-invention, where the public receives only a promise that a hypothesis might later prove useful; this would permit, and encourage, applicants to put placeholders on intriguing ideas to wait for the science to catch up and make it so. The patentee would enjoy the property right of excluding others from making, selling, using or improving that idea without the public’s having derived anything useful in return.
[Emphasis in original.]
AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 [AstraZeneca] The purpose of the utility requirement is to prevent the patenting of fanciful, speculative or inoperable inventions.
[56] The utility requirement serves a clear purpose. To avoid granting patents prematurely, and thereby limiting potentially useful research and development by others, the case law has imposed a requirement that an invention’s usefulness be demonstrated or soundly predicted at the time of application, rather than at some later point. This ensures patents are not granted where the use of the invention is speculative. What matters is that an invention be useful, in the sense that it carries out some useful known objective
and is not merely a laboratory curiosity whose only possible claim to utility is as a starting material for further research
(Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81 (Patent Appeal Board and Commissioner of Patents), at p. 91).
[57] The application of the utility requirement in s. 2, therefore, is to be interpreted in line with its purpose — to prevent the patenting of fanciful, speculative or inoperable inventions.